Details for New Drug Application (NDA): 202236
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The generic ingredient in DYMISTA is azelastine hydrochloride; fluticasone propionate. There are twelve drug master file entries for this compound. Five suppliers are listed for this compound. Additional details are available on the azelastine hydrochloride; fluticasone propionate profile page.
Summary for 202236
Tradename: | DYMISTA |
Applicant: | Mylan Speciality Lp |
Ingredient: | azelastine hydrochloride; fluticasone propionate |
Patents: | 2 |
Pharmacology for NDA: 202236
Mechanism of Action | Corticosteroid Hormone Receptor Agonists Histamine H1 Receptor Antagonists |
Suppliers and Packaging for NDA: 202236
Tradename | Generic Name | Dosage | NDA | Application Type | Supplier | National Drug Code | Package Code | Package |
---|---|---|---|---|---|---|---|---|
DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236 | NDA | Meda Pharmaceuticals Inc. | 0037-0245 | 0037-0245-23 | 1 BOTTLE, SPRAY in 1 BOX (0037-0245-23) / 120 SPRAY, METERED in 1 BOTTLE, SPRAY |
DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236 | NDA AUTHORIZED GENERIC | Mylan Pharmaceuticals Inc. | 0378-3458 | 0378-3458-23 | 1 BOTTLE in 1 BOX (0378-3458-23) / 120 SPRAY, METERED in 1 BOTTLE |
Profile for product number 001
Active Rx/OTC/Discontinued: | RX | Dosage: | SPRAY, METERED;NASAL | Strength | 0.137MG/SPRAY;0.05MG/SPRAY | ||||
Approval Date: | May 1, 2012 | TE: | AB | RLD: | Yes | ||||
Patent: | ⤷ Sign Up | Patent Expiration: | Feb 29, 2024 | Product Flag? | Substance Flag? | Delist Request? | |||
Patent: | ⤷ Sign Up | Patent Expiration: | Aug 24, 2026 | Product Flag? | Substance Flag? | Delist Request? | Y |
Expired US Patents for NDA 202236
Applicant | Tradename | Generic Name | Dosage | NDA | Approval Date | Patent No. | Patent Expiration |
---|---|---|---|---|---|---|---|
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Sign Up | ⤷ Sign Up |
Mylan Speciality Lp | DYMISTA | azelastine hydrochloride; fluticasone propionate | SPRAY, METERED;NASAL | 202236-001 | May 1, 2012 | ⤷ Sign Up | ⤷ Sign Up |
>Applicant | >Tradename | >Generic Name | >Dosage | >NDA | >Approval Date | >Patent No. | >Patent Expiration |
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